PMA P200015S011

Device: Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent
Applicant: Edwards Lifesciences, LLC
Product code: NPV
Decision date: 2021-12-16
Generic name: Pulmonary valve prosthesis percutaneously delivered
Approval order statement: Approval for the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent. The device is indicated for use in the management of pediatric and adult patients with severe pulmonary regurgitation as measured by echocardiography who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for pulmonary valve replacement.

Current openFDA PMA Record#

Device: Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent
Applicant: Edwards Lifesciences, LLC
PMA number: P200015
Supplement: S011
Product code: NPV
Generic name: Pulmonary valve prosthesis percutaneously delivered
Decision date: 2021-12-16
Decision code: APPR
Date received: 2021-06-21
Supplement type: Panel Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent. The device is indicated for use in the management of pediatric and adult patients with severe pulmonary regurgitation as measured by echocardiography who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for pulmonary valve replacement.